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Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury (UCMSC-ALI)

Primary Purpose

Acute Lung Injury, Acute Respiratory Distress Syndrome

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
UCMSC group
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring cellular therapy, acute lung injury, acute respiratory distress snydrome, human umbilical cord mesenchymal stem cell, phase 1/2 clinical study, allogeneic stem cell transplantation, ALI, ARDS

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent
  • Age between 35 and 70 y
  • Acute onset within 7 days.
  • Oxygenation index:200<PaO2/FiO2≤300mmHg; alveolar-arterial oxygen differences:P(A-a)O2>35mmHg
  • Bilateral infiltrates on chest radiography
  • No cardiac failure

Exclusion Criteria:

  • Declined to sign informed consent
  • Socially and mentally disabilities
  • Malignant diseases
  • Combined with severe infectious diseases
  • Patients with positive blood tests for Hepatitis B or Hepatitis C or HIV or tuberculosis at the time of screening
  • Pregnant or perinatal women
  • Severe diseases of any major organs

Sites / Locations

  • Department of Respiration,Affiliated Hospital to Academy of Military Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UCMSC group

Arm Description

Human umbilical cord MSCs are administrated to patients by intravenous infusion

Outcomes

Primary Outcome Measures

Safety will be determined by the assessment of major adverse events
Safety will be determined by the assessment of major adverse events defined as death, and the incidence of prespecified infusion-associated events and non-serious adverse events thought to be related to the MSC infusion.

Secondary Outcome Measures

Quantify pulmonary respiratory function measured by chest computerized tomography
The efficacy of UC-MSC treatment was measured by arterial blood gas analysis
The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-6
The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-8

Full Information

First Posted
May 8, 2015
Last Updated
May 11, 2015
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Ivy Institute of Stem Cells Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02444455
Brief Title
Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury
Acronym
UCMSC-ALI
Official Title
Safety and Efficacy of Human Umbilical-Cord-Derived Mesenchymal Stem Cell Transplantation in Acute Lung Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Ivy Institute of Stem Cells Co. Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study.
Detailed Description
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with acute lung injury,open label, controlled prospective study. Every patient will maintain their standard treatment of acute lung injury, with maximum tolerated dosage without side effects. The day of infusion will be considered day zero. From that moment, followup will be divided into 2,7,14 days. Clinical results will be analyzed after completion of 14 days of followup.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Acute Respiratory Distress Syndrome
Keywords
cellular therapy, acute lung injury, acute respiratory distress snydrome, human umbilical cord mesenchymal stem cell, phase 1/2 clinical study, allogeneic stem cell transplantation, ALI, ARDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UCMSC group
Arm Type
Experimental
Arm Description
Human umbilical cord MSCs are administrated to patients by intravenous infusion
Intervention Type
Biological
Intervention Name(s)
UCMSC group
Intervention Description
Human umbilical cord MSCs are transplanted by intravenous infusion(5×10^5/kg) once a day,a total of three times.
Primary Outcome Measure Information:
Title
Safety will be determined by the assessment of major adverse events
Description
Safety will be determined by the assessment of major adverse events defined as death, and the incidence of prespecified infusion-associated events and non-serious adverse events thought to be related to the MSC infusion.
Time Frame
From day 0 at the start of treatment to day 14.
Secondary Outcome Measure Information:
Title
Quantify pulmonary respiratory function measured by chest computerized tomography
Time Frame
Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.
Title
The efficacy of UC-MSC treatment was measured by arterial blood gas analysis
Time Frame
Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.
Title
The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-6
Time Frame
6 hours post-infusion, and days 1, 2, and 3
Title
The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-8
Time Frame
6 hours post-infusion, and days 1, 2, and 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent Age between 35 and 70 y Acute onset within 7 days. Oxygenation index:200<PaO2/FiO2≤300mmHg; alveolar-arterial oxygen differences:P(A-a)O2>35mmHg Bilateral infiltrates on chest radiography No cardiac failure Exclusion Criteria: Declined to sign informed consent Socially and mentally disabilities Malignant diseases Combined with severe infectious diseases Patients with positive blood tests for Hepatitis B or Hepatitis C or HIV or tuberculosis at the time of screening Pregnant or perinatal women Severe diseases of any major organs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changqing Bai, M.D.
Phone
+86-010-66947356
Email
baicq307@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Liu, M.D.
Organizational Affiliation
307-IVY Translational Medicine Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Changqing Bai, M.D.
Organizational Affiliation
Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Huiying Liu, M.D.
Organizational Affiliation
Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Respiration,Affiliated Hospital to Academy of Military Medical Sciences
City
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changqing Bai, M.D.
Phone
+86-010-66947356
Email
baicq307@163.com

12. IPD Sharing Statement

Learn more about this trial

Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury

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